This invention relates to the field of devices or appliances used to relieve or mitigate the problems associated with human urinary incontinence. More specifically, the present invention relates to a removable external closure for the human urethra.
Urinary incontinence, due to disease, injury, or other causes, is a troublesome problem for many individuals. Surgical intervention is often required to treat severe cases of incontinence, but in those cases where the patient suffers from only a partial loss of bladder control, or where the patient is otherwise a poor candidate for surgery, nonsurgical treatment is called for. While both male and female patients may be good candidates for nonsurgical treatment, such nonsurgical approaches are particularly appropriate for female patients who suffer from the partial, sporadic loss of bladder control sometimes referred to as xe2x80x9cstress incontinencexe2x80x9d or xe2x80x9curge incontinencexe2x80x9d. Such stress or urge incontinence, in fact, is the most common cause of urine loss in adult women.
Nonsurgical management of urinary incontinence includes non-therapeutic management, wherein the patient wears an appliance or device proximate the urethral orifice (xe2x80x9cmeatusxe2x80x9d) that collects or captures urinary discharge. Such devices fall generally into two categories: (1) urine collection devices, and (2) absorbent pads.
Urine collection devices typically comprise a receiving orifice or receptacle for capturing urine flowing from the urethra; retention means, associated with the receptacle or orifice, for holding the receptacle or orifice in the proximity of the urethral meatus; and means for directing urine from the receptacle or orifice to a reservoir or a container or the like for disposal. Devices of this general description, for use by female patients, are disclosed in the following U.S. Pat. Nos.: 3,512,185-Ellis; 3,661,155-Lindan; 4,412,511-Steer et al.; 4,457,314-Knowles; 4,484,917-Blackmon; 4,690,677-Erb; 4,822,347-MacDougall; and 4,846,819-Welch. A variation on the urinary collection device theme is the xe2x80x9cfemale external catheterxe2x80x9d, disclosed in U.S. Pat. No. 4,563,183-Barrodale et al., which includes a catheter tube having one end inserted into the urethra. In many of these devices, the retention means are configured so as to be inserted into the interlabial space, being retained therein by the anatomical structure of the external female genitalia. The Blackmaon and MacDougall devices also use an adhesive to assist in retention.
The category of absorbent pads includes a wide variety of devices, primarily for use by female patients, which generally comprise a body of absorbent material configured so as to be insertable into the interlabial space, and retained therein by the anatomical structure of the external female genitalia. Such devices typically resemble (and, indeed, can function as) catamenial sanitary napkins. The following U.S. Patents disclose devices that may generally be considered within this category: U.S. Pat. Nos. 3,983,873xe2x80x94Hirschman; 4,595,392xe2x80x94Johnson et al.; 4,627,848xe2x80x94Lassen et al.; 4,673,403xe2x80x94Lassen et al.; 4,743,245 xe2x80x94Lassen et al.; 4,804,380xe2x80x94Lassen et al.; and 4,846,824xe2x80x94Lassen et al. A sanitary napkin that is configured for interlabial retention, and that could be used to capture and absorb urine flow, is disclosed in British Patent No. 754,481.
While the above-described devices are useful in certain applications, they are subject to a number of disadvantages. For example, the urine collection devices require the user to wear a reservoir or container that may be prone to overflow or spillage. Also, such devices are better suited to users who suffer from chronic or severe loss of bladder function, rather than those who suffer only from moderate stress or urge incontinence. The absorbent pads tend to be bulky, and may be uncomfortable for some users, especially when wet. Odor associated with urine collection devices is often noticeable by others, and is therefore undesirable.
Use of the prior art devices described above is based upon the assumption that the flow of urine out of the urethra cannot or should not be stopped. This assumption may not be true in many cases of stress or urge incontinence, which are transient in nature. In such cases, external occlusion of the urethral meatus may provide an adequate degree of continence for many patients, but this approach has been overlooked, at least for the most part, by the prior art.
There is, therefore, a need for a device that provides for the effective management of urinary incontinence by means of the external occlusion of the urethral meatus; that is easy to use and comfortable to wear; and that provides for secure retention with good sealing qualities.
Broadly, the present invention is a urethral meatus occlusion device, comprising a resilient body, configured to engage and seal against the urethral meatus, and to be retained in place by engagement with the anatomical structure of the external genitalia. More specifically, in one preferred female embodiment, the body is a pad that includes a base, having a substantially triangular or arrowhead-shaped outline, that is adapted to seat against the vestibule of the vulva, anteriorly of the vaginal orifice, thereby occluding the urethral meatus. The lateral edges of the pad are configured to fit inside the labia minora, the engagement between the pad and the labia thereby retaining the pad firmly against the vestibule, in sealing engagement against the meatus. The side of the pad opposite the base is configured with a central longitudinal ridge that, when the pad is installed in the vestibule, extends into the interlabial space. A loop of thread may be inserted through the ridge to facilitate removal of the device, or a finger hole may be provided into the posterior of the ridge for the same purpose.
In a second preferred female embodiment of the invention, the pad has a substantially tubular configuration, and thus lacks the lateral edges or xe2x80x9cwingsxe2x80x9d of the first preferred female embodiment. This xe2x80x9cwinglessxe2x80x9d embodiment is adapted for use where the floor of the vestibule is narrower than what may be considered xe2x80x9cnormalxe2x80x9d. As with first preferred female embodiment, the pad seats against the floor of the vestibule, anteriorly of the vaginal orifice, thereby occluding the urethral meatus. The tubular portion of the pad is configured to fit inside the labia minora, the engagement between the pad and the labia thereby retaining the pad firmly against the vestibule, in sealing engagement against the meatus. The side of the pad opposite the base is configured with a central longitudinal ridge that, when the pad is installed in the vestibule, extends into the interlabial space, thereby facilitating insertion and removal.
In both of the aforementioned embodiments, at least that portion of the pad that lies in sealing engagement against the meatus is coated with a pressure-sensitive, hydrophilic hydrogel adhesive for retention against the vestibule. The adhesive, in concert with the resilient pad, spreads to fill the interlabial space proximate the vestibule, thereby providing a conformal fit with the anatomical structure, which enhances the retention of the device. The pad itself can be coated or impregnated with a suitable anti-bacterial or germicidal agent to inhibit infection.
In a third preferred female embodiment of the invention, the body comprises an elastomeric bladder or sac, filled with a soft, compliant, biocompatible gel or liquid, and coated with a pressure-sensitive hydrophilic hydrogel adhesive, to enhance retention. The gel-filled sac spreads within the interlabial space to conform closely to the anatomic structure of the external female genitalia, and thereby seals against the urethral meatus, with the aid of the adhesive.
In several embodiments suitable for use by a male patient, the invention comprises a thin, resilient, absorbent pad, the inner surface of which is provided with a pressure-sensitive hydrophilic hydrogel adhesive layer. The pad conforms to the glans of the penis, and it is removably attached to the penis by means of the adhesive, whereby the adhesive also seals against and occludes the urethral meatus. In one such male embodiment, the pad has a substantially elliptical central portion, with a pair of laterally-extending tabs at each end that are wrapped around the glans for securing the pad in place. In another male embodiment, the pad has a central sealing portion with a plurality of radially-extending tabs for securing the device. In still another male embodiment, the pad is in the configuration of a generally hemispherical cap that covers a substantial portion of the glans. As with the female embodiments, the pad of the male embodiments can be coated or impregnated with a medicinal compound, such as an anti-bacterial or germicidal agent.
It will be appreciated that the present invention offers a new and advantageous approach to the management of incontinence. For example, the device is small, unobtrusive, easy to use, and comfortable to wear. By allowing the user effectively to retain urine, the device avoids the problems associated with prior art devices, enumerated above, that allow the discharge of urine. The device can be made in a variety of sizes and shapes for optimal fit for each individual user. The device is economical to manufacture, and can, therefore, be a disposable item.
These and other advantages will be better appreciated from the detailed description that follows.